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Last updated: 8 days ago
Computer System Validation Engineer

Computer System Validation Engineer

CAIVacaville, California, United States, 95687
Full-time
Quick Apply
CAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project...Show moreLast updated: 8 days ago
PART TIME INSTRUCTOR POOL - COMPUTER SCIENCE

PART TIME INSTRUCTOR POOL - COMPUTER SCIENCE

Grossmont-Cuyamaca Community College DistrictSan Diego County
Part-time
Transforming lives through learning isn’t just the vision of the Grossmont-Cuyamaca Community College District.It happens every day with our 30,000 students who take the first step in their higher ...Show moreLast updated: 30+ days ago
COMPUTER SCIENCE

COMPUTER SCIENCE

Santa Rosa Junior CollegeSonoma County, CA
Full-time +1
Santa Rosa Junior College is currently accepting applications to establish a pool for part-time associate faculty assignments. Associate assignments are temporary, part-time or on-call.This job post...Show moreLast updated: 30+ days ago
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Computer System Validation Engineer

Computer System Validation Engineer

CAIVacaville, California, United States, 95687
8 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Are You Ready?

CAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.

Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.

Our Foundational Principles :

  • We act with integrity
  • We serve each other
  • We serve society
  • We work for our future

With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values :

  • Team Before Self
  • Respect for Others
  • Can-Do Attitude
  • Key Responsibilities

    Documentation & Compliance

  • Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
  • Generate and execute test protocols and scripts
  • Ensure adherence to 21 CFR Part 11 and data integrity principles
  • Review and contribute to validation plans and risk assessments
  • System & Industry Expertise

  • Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
  • Engage with major systems and platforms such as Rockwell PharmaSuite, Emerson Syncade, DeltaV, PI, GE, ABB, Siemens,
  • Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware

  • Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
  • Utilize familiarity with S88 / S95 batch control standards
  • Client Support & Technical Execution

  • Support client engagements with strong customer-service orientation
  • Perform system assessments and remediation related to data integrity
  • Collaborate with client teams to ensure validation compliance and delivery
  • Qualifications and Experience

  • Bachelor’s degree (BS / BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
  • Minimum of 3+ years of experience in computer systems validation
  • Experience in biotech or pharmaceutical environments preferred over medical device
  • In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
  • Familiarity with S88 / S95 batch control standards
  • Experience with multiple automation and manufacturing execution systems is highly desirable
  • Data integrity assessment / remediation experience is a plus
  • Other Requirements

  • Excellent oral and written communication skills in English
  • Ability to travel domestically and internationally as required
  • Willingness to work paid overtime when needed
  • Must be authorized to work in the U.S. without current or future sponsorship
  • Critical Competencies

    Influence Strategy

  • Pursues opportunities based on organizational fit and strategy
  • Identifies high-impact, innovative solutions
  • Satisfy the Customer

  • Anticipates and meets client needs
  • Delivers high-quality solutions and maintains satisfaction
  • Plan for Success

  • Aligns business goals with execution plans
  • Allocates resources and builds risk mitigation strategies
  • Pursue Execution

  • Prioritizes effectively and ensures accountability
  • Proactively addresses challenges
  • Tailor Communication

  • Communicates clearly and professionally
  • Adapts style for technical and non-technical audiences
  • Build Partnerships

  • Builds cross-functional networks
  • Promotes collaboration and stakeholder engagement
  • Influence Others

  • Gains support through sound reasoning
  • Promotes innovation and value
  • Develop Self and Others

  • Demonstrates integrity and commitment to growth
  • Builds effective relationships internally and externally
  • LI-MV1

    Average base salary range - not including benefits, and potential overtime and / or Cost of Living Adjustment.

    Benefits

    Competitive compensation

    Up to 15% retirement contribution

    24 days PTO + 5 sick days annually

    Low-cost health insurance for employees

    70% long-term disability coverage paid by the company

    Financial support for internal / external education and certifications

    We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

    This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

    PI274616328